IDENTIFICATION OF SYNOVIAL BIOMARKERS OF RESPONSE TO IXEKIZUMAB IN REFRACTORY PSORIATIC ARTHRITIS: THE PRECISE STUDY.
Key facts
- Where
- Ferrara, Monza és Udine, OlaszországSee the 3 sites
- Phase
- 4. fázis
Where in Olaszország
- University Hospital Of FerraraFerrara, OlaszországTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, OlaszországTaking people
- Azienda Sanitaria Universitaria Friuli CentraleUdine, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Of Ferrara
- Trial code
- EU 2025-521259-21-00
- Record updated
- 2026. szeptember 10.
- Original description
The primary objective of the study is to evaluate if synovial biomarkers modifications in culture supernatants and cellular homogenates (after in vitro administration of IXE in assays of different cells/tissues obtained from refractory PsA patients) predict clinical response to systemic IXE at 12 weeks.Read full original descriptionShow less
The primary objective of the study is to evaluate if synovial biomarkers modifications in culture supernatants and cellular homogenates (after in vitro administration of IXE in assays of different cells/tissues obtained from refractory PsA patients) predict clinical response to systemic IXE at 12 weeks.
Inclusion: Confirmed diagnosis of PsA, according to an expert physician, and fulfilling the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria (55); 2. Age greater than or equal to 18 years; 3. Active disease (defined as 3 or more swollen joints AND 3 or more tender joints); 4. Potential indication to (new) bDMARD therapy with IXE according to treating physician opinion, in line with international and national recommendations (3,57) and product data sheet; 5. Patients refractory to previous (at least 1) csDMARDs therapies (incomplete response, loss of efficacy or adverse events), naïve to b/tsDMARDs; 6. One of the involved joints has to be appropriate for US-guided synovial biopsy; 7. Patients must provide written informed consent; 8. Oral prednisone at doses of ≤10 mg/day (stable for at least 4 weeks); 9. No concomitant csDMARDs or concomitant background csDMARDs stable for at least 4 weeks.
Exclusion: Contraindication to start a new bDMARD treatment course; 2. Previous treatment with bDMARDs (any, included anti-IL17A agents) or tsDMARDs (any); 3. Contraindication to US-guided synovial biopsy (e.g. uncontrolled haemostatic disorders, allergies to local anaesthetics); 4. Previous treatment with intra-articular steroids within the previous 1 month; 5. Patients with dementia or an altered mental status, which would preclude the understanding and rendering of informed consent; 6. Known allergy or hypersensitivity to any biologic therapy; 7. Administration of live attenuated vaccine(s) (LAVs) within 6 weeks of enrolment. Or intended use of LAV during the treatment period; 8. Any history of malignancy in the last 5 years except for completely resected squamous or basal cell carcinoma of the skin; 9. For women of childbearing potential: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3- months after study completion; 10. Known immunodeficiency or patients immunocompromised to an extent that participation in the study would pose and unacceptable risk to the patient; 11. Clinically relevant (chronic or acute) infections, including untreated (latent) tuberculosis, hepatitis B or C or HIV infections; 12. Subjects with other autoimmune disease, e.g. Crohn's disease, Ulcerative colitis and Graves disease, except celiac disease and hypothyroidism which do not need to be excluded.